Critical Incident During Anaesthesia

Safety Issues Clinical Trial

Official title:

Critical Incident During Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435287
• Other study ID #: B77KL32iv5
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A multicenter study in Ukrainian hospitals on compliance with the requirements for responding to critical cases in the operating room, and the availability of relevant documentation and checklists.

Description:

Timely information and response to emergencies are important both in the context of patient safety and in the context of the hospital economy. The availability of information systems is one of the security requirements of the Helsinki Declaration of Patient Safety.

Ukraine has only just begun its path to implementing the Declaration of Helsinki in Ukrainian hospitals. The level of adherence to the recommendations can vary considerably depending on the region, the provision of the hospital and the effectiveness of the institution's internal management. In our survey of Ukrainian hospitals, only 74% of hospitals kept records of anaesthesia complications in general, with only 46% having separate electronic or paper documents to record complications; Also, the majority of respondent physicians (62.9%) reported the absence of checklists or algorithms for actions in case of emergencies or emergencies during anaesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• critical incident during anaesthesia: massive hemorrhage >1000ml, difficult intubation, severe hypotension, severe bradycardia, desaturation, cardiac arrest, high spinal block, anesthetic toxicity, miocardial ischemia, severe arhytmia etc

Exclusion Criteria:

• critical incidents without aneasthesia

Related Conditions & MeSH terms

• Critical Incident
• Safety Issues

Locations

Country	Name	City	State
Ukraine	Bogomolets NMU	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

References & Publications (4)

Agbamu, P.O Et...al (2016) Critical Incidents and Near Misses During Anaesthesia: a Prospective Audit.13th Annual Scientific, Conference and Gathering Held at College of Medicine, University of Lagos, Idi Araba.

Ahluwalia J, Marriott L. Critical incident reporting systems. Semin Fetal Neonatal Med. 2005 Feb;10(1):31-7. Review. — View Citation

Amucheazi AO, Ajuzieogu OV. Critical incidents during anesthesia in a developing country: A retrospective audit. Anesth Essays Res. 2010 Jul-Dec;4(2):64-8. doi: 10.4103/0259-1162.73508. — View Citation

Liu EH, Koh KF. A prospective audit of critical incidents in anaesthesia in a university teaching hospital. Ann Acad Med Singap. 2003 Nov;32(6):814-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Critical Incident During Anaesthesia	Critical Incident During Anaesthesia	5 months
Secondary	The use of the WHO Safe Surgery checklist	The use of the WHO Safe Surgery checklist	5 months
Secondary	Keeping records of the critical incidents	Keeping records of the critical incidents during anaesthesia	5 months